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BioPharma Drug Approval

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested u...

April 21, 2023 | News

CARsgen's CT041 receives IND clearance from NMPA for pancreatic cancer therapy.

Dr Raffaele Baffa, Chief Medical Officer of CARsgen, commented that "We are glad to receive the IND clearance from NMPA for the adjuvant treatment of ...

April 20, 2023 | News

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...

April 20, 2023 | News

Crystal Formulation Services Receives China Drug Manufacturing License for Milestone Formulation Capability

Crystal Formulation Services, a subsidiary of Crystal Pharmatech, has achieved an exciting new milestone in its formulation capabilities. The company was r...

April 20, 2023 | News

Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma

A few months earlier, the Company's first product (BRG01) targeting relapsed/metastatic nasopharyngeal cancer has been granted IND approval by both the US ...

April 19, 2023 | News

FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for...

April 17, 2023 | News

Minghui Pharma's MH004 Cream Succeeds in Phase 2 Trial for Atopic Dermatitis, Global Phase 3 MRCT Cleared by FDA

Study met both primary and all key secondary endpoints Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score was -78.7% in...

April 14, 2023 | News

Biosyngen received China NMPA IND approval for its T-cell redirection therapy targeting EBV-positive Lymphoma

Currently, commercially available cell therapies, such as CD19 CAR-T, are designed for the treatment of B cell lymphoma or acute lymphoblastic leukemia. Tr...

April 12, 2023 | News

Boan Biotech's Biologics License Application for Boyounuo® (Bevacizumab Injection) Accepted in Brazil

Envisioned to be "a leading global biopharmaceutical company", Boan Biotech develops biologics for both Chinese and international markets, including E...

April 12, 2023 | News

JW Therapeutics' Relma-cel approved for systemic lupus erythematosus trial.

SLE is a complex autoimmune disease with diverse clinical manifestations involving many organs and systems. It is estimated that China has 1 mill...

April 11, 2023 | News

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (...

April 11, 2023 | News

Tillotts Pharma AG announces the launch of Octasa® 1600 mg tablets in Canada

The expansion of the Octasa® family in Canada with the launch of Octasa® 1600 mg represents an important step in the strategic partnership of Tillo...

April 07, 2023 | News

Leica Biosystems Strengthens Portfolio with FDA Clearance of Class II Mismatch Repair (MMR) Panel

Leica Biosystems announced the US Food and Drug Administration (FDA) 510(k) clearance of the BOND MMR Antibody Panel, providing customers with a high-perfo...

April 04, 2023 | News

ImmVira's MVR-C5252 for Malignant Glioma Approved for Clinical Trial in China

In July 2022, the Company entered into a cooperative agreement with China Resource Biopharma ("CRBio") to jointly develop MVR-C5252 in the Greate...

March 30, 2023 | Regulatory

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